Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)
<p><strong>Background</strong></p> The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, fee...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
BioMed Central
2024
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| _version_ | 1824459180875972608 |
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| author | Ball, S Reardon, T Creswell, C Taylor, L Brown, P Ford, T Gray, A Hill, C Jasper, B Larkin, M Macdonald, I Morgan, F Pollard, J Sancho, M Sniehotta, FF Spence, SH Stainer, J Stallard, P Violato, M Ukoumunne, OC |
| author_facet | Ball, S Reardon, T Creswell, C Taylor, L Brown, P Ford, T Gray, A Hill, C Jasper, B Larkin, M Macdonald, I Morgan, F Pollard, J Sancho, M Sniehotta, FF Spence, SH Stainer, J Stallard, P Violato, M Ukoumunne, OC |
| author_sort | Ball, S |
| collection | OXFORD |
| description | <p><strong>Background</strong></p>
The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial.
<p><strong>Methods and design</strong></p>
iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses.
<p><strong>Trial registration</strong></p>
ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022. |
| first_indexed | 2025-02-19T04:37:42Z |
| format | Journal article |
| id | oxford-uuid:477f7aab-f819-40ed-ba47-cf120be8b596 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2025-02-19T04:37:42Z |
| publishDate | 2024 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:477f7aab-f819-40ed-ba47-cf120be8b5962025-02-05T16:57:04ZStatistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:477f7aab-f819-40ed-ba47-cf120be8b596EnglishSymplectic ElementsBioMed Central2024Ball, SReardon, TCreswell, CTaylor, LBrown, PFord, TGray, AHill, CJasper, BLarkin, MMacdonald, IMorgan, FPollard, JSancho, MSniehotta, FFSpence, SHStainer, JStallard, PViolato, MUkoumunne, OC<p><strong>Background</strong></p> The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. <p><strong>Methods and design</strong></p> iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. <p><strong>Trial registration</strong></p> ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022. |
| spellingShingle | Ball, S Reardon, T Creswell, C Taylor, L Brown, P Ford, T Gray, A Hill, C Jasper, B Larkin, M Macdonald, I Morgan, F Pollard, J Sancho, M Sniehotta, FF Spence, SH Stainer, J Stallard, P Violato, M Ukoumunne, OC Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title | Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title_full | Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title_fullStr | Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title_full_unstemmed | Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title_short | Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) |
| title_sort | statistical analysis plan for a cluster randomised controlled trial to compare screening feedback and intervention for child anxiety problems to usual school practice identifying child anxiety through schools identification to intervention icats i2i |
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